Medgenics (NYSE AMEX: MDGN) is developing and commercializing Biopump, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own skin biopsy for the treatment of a range of chronic diseases including anemia, hepatitis C and hemophilia. Medgenics believes this approach has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins.
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Medgenics (NYSE AMEX: MDGN) - Investor Fact Sheet
1. NYSE Amex: MDGN
AIM: MEDU/MEDG
Recent stock price (7/13/11) $5.05
52-week range $2.85 - $4.56
Market capitalization $48.6 mil.
Shares outstanding 9.6 mil.
Cash position (post 4/2011 IPO) $13.3 mil.
Fiscal year-end Dec. 31
Medgenics is developing and commercializing Biopump for the treatment of a range of chronic diseases, with initial
development programs in anemia, hepatitis C and hemophilia. Biopump is a proprietary platform technology for the
sustained production and delivery of therapeutic proteins using the patient!s own dermis tissue. Medgenics believes
its approach has multiple benefits compared with current treatments, which include regular and costly injections of
therapeutic proteins. Medgenics intends to develop its innovative products and bring them to market via strategic
partnerships with major pharmaceutical and/or medical device companies. HEMODURE is the subject of cooperation
between Medgenics and Baxter International, a market leader in hemophilia. In addition to treatments for anemia,
hepatitis C and hemophilia, Medgenics plans to develop and/or out-license a pipeline of future Biopump products
targeting the large and rapidly growing global market for protein therapies. Other potential applications for Biopump
include multiple sclerosis, arthritis, pediatric growth hormone deficiency, obesity and diabetes.
INVESTMENT HIGHLIGHTS
The Biopump system holds disruptive potential in the Biopump addresses multi-billion dollar market
treatment of chronic diseases opportunities in anemia, hepatitis C and hemophilia
Biopump is a platform for sustained production of EPODURE (completing a Phase I/II dose-ranging trial)
therapeutic proteins using the patient!s own tissue to produce and deliver EPO for many months from a
Biopump has shown proof of concept with EPODURE, single administration, has demonstrated elevation and
producing sustained dosing of erythropoietin (EPO) with stabilization of hemoglobin levels in anemic patients
unprecedented results in patients, having delivered for 6 to 28 months
therapeutic protein in 14 patients for 6 months to more INFRADURE (plans to commence a Phase I/II trial in
than 28 months Israel in 2011) to produce a sustained therapeutic
Biopump potentially is a highly cost-effective treatment dose of interferon-alpha for use in the treatment
Biopump is designed to be implemented using standard
hepatitis C
facilities and procedures
HEMODURE is a sustained Factor VIII therapy for the
Biopump provides a simplified treatment pathway prophylactic treatment of hemophilia, in development
Biopump delivers known proteins in routine clinical use, in cooperation with Baxter International
with superior delivery and patient compliance
Using the patient!s own protein optimizes safety; there The broad-based technology platform allows for
are no peak overdose or under-dose between injections multiple partnership opportunities
There are excellent partnership prospects following
The Biopump is cost efficient and scalable proof-of-concept, with significant revenue potential
Manufacturing process is proven on >5,000 Biopumps The first development and commercial agreement is
An automated bioprocessor with sealed cassettes is in already in place, for HEMODURE with Baxter
development
Strong executive and board leadership
Medgenics enjoys a strong IP position The management team has significant healthcare and
10 patents are issued on Biopump and >50 are pending commercial development experience
Key licenses have been acquired, including a Factor VIII Executives have a legacy of founding, operating and
license from the University of Michigan leading firms to M&A totaling billions of dollars
THE BIOPUMP SYSTEM
a) Harvest dermis tissue (micro-organs) from
b b)
the patient
Transfer to processing station
a c) Adenoviral gutless vector carrying gene
for desired protein
d) Process each micro-organ into Biopump
c e)
f)
Biopump producing protein
Measure daily protein production per
h d Biopump for dosing
i f e
g)
h)
Wash several days to remove vector
Re-implant Biopumps subcutaneously per
desired dosing
g i) Sustained local delivery for life of cells in
Biopump (>6 months)
2. REPEAT BOLUS INJECTIONS vs. BIOPUMP
The Biopump is designed to maintain
blood protein levels (green area in graph)
within the intended dose range
(therapeutic window) by sustained protein
production over a period of several
months
The number of Biopumps that are
implanted in each patient is determined
by the desired dose and the production
output of each Biopump
The Biopump has the potential to spare
patients the side effects of overdose
associated with frequent bolus injections
and lack of efficacy when protein levels
drop below the therapeutic window
between injections (red line in graph)
Addressing the needs of millions of patients with protein sales >$16 billion
Anemia Hepatitis C Hemophilia
Injected EPO Injected IFN-a Injected Factor VIII
$9.6 billion (2009) $2.6 billion (2009) $4.0 billion (2009)
Amgen, J&J, Roche Merck, Roche, GSK Baxter, Bayer,
Wyeth
POTENTIAL CLINICAL & ECONOMIC ADVANTAGES OF THE BIOPUMP
Increased efficacy
Sustained dose within the therapeutic window
Improved safety
Uses the patient!s own protein; not produced in rodent cells The Biopump
Fewer side effects resulting from overdose/drug spikes therapeutic system
Improved patient compliance
Replaces frequent injections could change the
Reliable treatment; not dependent on patient involvement paradigm for the
Reduced costs
Eliminates need for an expensive protein manufacturing facility
treatment of chronic
Reversible treatment diseases
Simple process to reverse (ablation)
INVESTOR CONTACTS UPCOMING MILESTONES
Andrew Pearlman, Ph.D.
Medgenics, Inc. EPODURE: Complete Phase I/II trial; seek IND for Phase
+972-4-902-8900 IIb, other pre-trial preparations to be conducted for launch in
andy@medgenics.com renal anemia
INFRADURE: Prepare, launch and obtain initial data from the
Eugene Bauer, M.D. Phase I/II trial in hepatitis C
Medgenics, Inc.
HEMODURE: Improve FVIII production and delivery in mice,
(415) 568-2246
eugene.bauer@medgenics.com towards levels sufficient for clinical studies in patients with
hemophilia
Anne Marie Fields Partnering: Pursue strategic alliances for identified and
Senior Vice President future indications
Lippert/Heilshorn & Associates, Inc. Core Technology: Further develop and refine the platform
(212) 838-3777
afields@lhai.com
technology
The information contained in this summary was obtained from the management of Medgenics, Inc. and other sources Lippert/Heilshorn & Associates (LHA) believes to be reliable. It does not
constitute an offer to sell or a solicitation of an offer to buy any securities of the company. LHA is Medgenics! investor relations firm. Except for the historical information contained in this
summary, the matters discussed herein are forward-looking statements, the accuracy of which is subject to risks and uncertainties. Medgenics undertakes no obligation to update or revise any
forward-looking statements. For additional information about Medgenics and its operations and related risks, please refer to the Company's SEC filings. July 2011